Interlabial device

ABSTRACT

Absorbent devices, and more particularly absorbent devices that are worn interlabially by female wearers for catamenial purposes, incontinence protection, or both, are disclosed. The interlabial absorbent device of the present invention comprises a main absorbent portion and a pair of flexible extensions joined to the main absorbent portion. The main absorbent portion has a distal surface and comprises an acquisition member and at least one storage member, in fluid communication with the acquisition member, that is disposed laterally outboard of the acquisition member. In use, the distal surface of the main absorbent portion is positioned furthest inward into the space between the wearer&#39;s labia majora. The pair of flexible extensions extends downwardly and laterally outward from the distal surface, and preferably is capable of maintaining contact with the inside surfaces of the wearer&#39;s labia majora when the wearer&#39;s body goes through a range of motions, including squatting. Additionally, the flexible extensions are preferably capable of covering the fingertips of the wearer as the absorbent device is inserted into the interlabial space. The interlabial device further preferably comprises a backsheet that is disposed on the surface of the flexible extensions that is opposite the body contacting surface thereof and on all surfaces of the main absorbent portion except the proximal surface.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This is a continuation of application Ser. No. 08/876,206 filedJun. 16, 1997, pending.

FIELD OF THE INVENTION

[0002] This invention relates to absorbent devices, and moreparticularly to an interlabial absorbent device, adapted to manage thevarious components of menses in a manner that makes more effective useof the absorbent capacity of the device. Such device are typically usedby female wearers for catamenial purposes.

BACKGROUND OF THE INVENTION

[0003] The development of highly absorbent articles for blood andblood-based fluids such as catamenial products (e.g., sanitary napkins,tampons, or interlabial devices), would dressings, bandages and surgicaldrapes can be challenging. Compared to water and urine, blood and bloodbased fluids such as menses are relatively complex mixtures of dissolvedand undissolved components (e.g., erythrocytes or red blood cells). Inparticular, blood-based fluids such as menses are much more viscous thanwater and urine due to undissolved components and high viscosity mucosalcomponents. This higher viscosity hampers the ability of conventionalabsorbent materials to efficiently and rapidly transport theseblood-based fluids to regions remote from the point of initialdischarge. For example, undissloved components of these blood-basedfluids can potentially clog the capillaries of these absorbent materialsand high viscosity mucosal components can significantly slow absorptionrate. This makes the design of appropriate absorbent systems forblood-based fluids such as menses particularly difficult.

[0004] In the case of catamenial products, women have come to expect ahigh level of performance in terms of comfort and fit, retention offluid, and minimal staining. Above all, leakage of fluid from the padonto undergarments is regarded as totally unacceptable. Improving theperformance of such catamenial products continues to be a formidableundertaking, although a number of improvements have been made in bothcatamenial structures, and materials used in such structures. However,eliminating leakage, particularly along the inside of the thighs,without compromising fit and comfort, has not always met the desiredneeds of the consumer.

[0005] Sanitary napkins of the current art have attempted to addressabsorption of high viscosity bodily fluids, such as menses in variousways. For example, U.S. Pat. No. 4,973,325, issued to Sherrod, et al. onNov. 27, 1990, provides a transfer member said to facilitate movement ofbody fluids downward and outward to distant areas of the absorbent. Thetransfer member, which is positioned above, between and beneath theabsorbents, comprises a material intended to readily transfer fluids aswell as give up fluid to a cellulosic absorbent. While such a structuremay represent an improvement in fluid distribution, the ability tofacilitate movement of fluids to distant areas of an absorbent mayrequire a porous network with a pore size distribution sufficientlysmall (for capillary wicking)l that it can become clogged by the solidcomponents of menses. In another example, U.S. patent application Ser.No. 08/382,921, filed in the name of Horney, et al. on Feb. 3, 1995 andpublished as PCT Application WO 96/23474 on Aug. 8, 1996, describes anabsorbent article having an acquisition component having a pore size inthe range of red blood cells, suspended solids, and the like. Theacquisition component traps and stores (i.e. filters) such componentsfrom the bodily exudate allowing lower viscosity components to passthrough for storage in a small pore storage component. Filtering bodilyfluids, such as menses, has clear advantages in making use of absorbentcapacity. However, the act of filtering a component means that the poresthat filtered the component are no longer available for rapid absorptionor transport of fluids (i.e. that pore is clogged). However, clogging isof less importance for an externally worn device, such as that describedin the Horney, et al. application, than it would be for a device fittingclose to a source of bodily fluids, such as an interlabial product,because externally worn devices are typically larger than internallyworn devices and bodily fluids can flow to an unclogged portion forabsorption.

[0006] Interlabial pads have the potential to provide a significantlyreduced risk of leakage because they are positioned in close proximityto the vaginal introitus enabling them to intercept bodily fluids suchas menses almost immediately after discharge. Numerous attempts havebeen made in the past to produce an interlabial pad which would combinethe best features of tampons and sanitary napkins while avoiding atleast some of the disadvantages associated with each of these types ofdevices. Examples of such devices are described in U.S. Pat. No.2,917,049 issued to Delaney on Dec. 15, 1959, U.S. Pat. No. 3,420,235issued to Harmon on Jan. 7, 1969, U.S. Pat. No. 4,595,392 issued toJohnson, et al. on Jun. 17, 1986, and U.S. Pat. Nos. 5,074,855 and5,336,208 issued to Rosenbluth, et al. on Dec. 24, 1991 and Aug. 9, 1994respectively, and U.S. Pat. No. 5,484,429 issued to Vukos, et al. onJan. 16, 1996. A commercially available interlabial device is FRESH 'NFIT® Padette which is marketed by Athena Medical Corp. of Portland, Ore.and described in U.S. Pat. Nos. 3,983,873 and 4,175,561 issued toHirschman on Oct. 5, 1976 and Nov. 27, 1979, respectively.

[0007] However, many of these devices have not met with great commercialsuccess. There are drawbacks associated with all of the above products.For example, the device described in the Delaney patent does not appearto be capable of an easy and comfortable insertion, due to thepossibility of the layers of absorbent material opening up duringinsertion. The commercially available Padette product suffers from thedisadvantage that they may not provide protection when a wearer squats.

[0008] Further, capillaries on or near the surface of the of suchproducts that is presented to the body may not be able to rapidly absorbthe viscous components of bodily exudates, such as menses, or thesurface capillaries may become clogged with particulate material, suchas cellular debris. Such clogging can reduce absorption efficiency andresult in increased risk of leakage.

[0009] Thus, a need exists for an interlabial device that is small insize and that can be easily inserted and that provides protectionagainst incontinence, menstrual discharges, and discharges of bodilyexudates throughout a wide range of wearer motions.

[0010] A need further exists for an interlabial device that resistsclogging by components of bodily exudates, such as viscous fluids andcellular debris. Clogging of surface capillaries is not a significantissue for catamenial devices of the current art that are not worninterlabially, such as sanitary napkins, because fluid can spread overtheir relatively large surface area bypassing any clogged portions. Thatis, if a small portion of the surface of a sanitary napkin becomesclogged by cellular debris or the like, bodily fluid can readily move toan unclogged area for absorption. Also, catamenial devices of thecurrent art frequently do not have sustained bodily fit so the devicecan move relative to the body. As a result, bodily exudates may bedeposited on one portion of the device at one time and on anotherportion of the device at another time, reducing the risk of clogging agiven portion. On the other hand, an interlabial device is held inrelatively the same position with respect to a wearer's vaginalintroitus and urethral opening throughout a full range of wearermotions. As a result, bodily exudates are continually deposited on thesame portion of the interlabial device. This means the risk of cloggingmay be higher for an interlabial device when compared to othercatamenial devices of the current art.

[0011] Therefore, it is an object of the present invention to provide aninterlabial absorbent device that is small in size and is easy toinsert.

[0012] It is another object of the present invention to provide aninterlabial absorbent device that consistently blocks both the vaginalintroitus and the urethral opening so that it provides protectionagainst menstrual discharges, incontinence, and discharges of bodilyexudates throughout a wide range of wearer motions.

[0013] It is still another object of the present invention to provide aninterlabial absorbent device that “manages” the absorption of highviscosity or insoluble components of bodily fluids such as menses byresisting capillary clogging by such components.

[0014] These and other objects of the present invention will become morereadily apparent when considered in reference to the followingdescription and when taken in conjunction with the accompanyingdrawings.

SUMMARY OF THE INVENTION

[0015] This invention relates to absorbent devices, and, moreparticularly, to an absorbent device that is insertable into theinterlabial space of a female wearer for catamenial purposes,incontinence protection, or both.

[0016] The interlabial absorbent device of the present inventioncomprises a main absorbent portion and a pair of flexible extensionsjoined to the main absorbent portion. The main absorbent portioncomprises an acquisition member that can rapidly absorb bodily fluids,such as menses, without becoming clogged with solid or high viscositycomponents of such fluids. The main absorbent portion further comprisesa storage member that is in effective fluid contact with the acquisitionmember. The storage member has a pore volume distribution which enablesit to draw absorbed bodily fluids from the acquisition member. Theinterlabial device further comprises a pair of flexible extensions whichare joined to the main absorbent portion adjacent a proximal surfacethereof. The proximal surface is that surface of the main absorbentportion that is positioned furthest inward into the space between thewearer's labia when the interlabial device is inserted. Upon insertion,the flexible extensions contact and tend to adhere to the walls of awearer's labia. The flexible extensions are also preferably capable ofcovering the wearer's fingertips as the absorbent device is insertedinto the interlabial space of the wearer.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] While the specification concludes with claims particularlypointing out and distinctly claiming the subject matter which isregarded as forming the present invention, it is believed that theinvention will be better understood from the following description takenin conjunction with the accompanying drawings, in which:

[0018]FIG. 1 is a perspective view of a preferred embodiment of theinterlabial absorbent device of the present invention.

[0019]FIG. 2 is an end view of the absorbent device shown in FIG. 1.

[0020]FIG. 3 is a perspective view of an alternative preferredembodiment of the interlabial absorbent device of the present invention.

[0021]FIG. 4 is an end view of an alternative preferred embodiment ofthe present invention having a pleated main absorbent portion.

[0022]FIG. 5 is an end view of an alternative embodiment of the pleatedembodiment shown in FIG. 4.

[0023]FIG. 6 is a preferred embodiment of the present invention showinga main absorbent portion having a multiple layer structure.

[0024]FIG. 7 is a cross-sectional view of a wearer's body surroundingand including the wearer's labia majora and labia minora showing theflexible extensions of the present invention covering the wearer'sfingertips as the absorbent device of the present invention is insertedinto the wearer's interlabial space.

[0025]FIG. 8 is a cross-sectional view of the same region of thewearer's body shown in FIG. 7 showing how the interlabial absorbentdevice of the present invention fits when the wearer is standing.

DETAILED DESCRIPTION OF THE INVENTION

[0026] General Description of the Interlabial Absorbent Device

[0027] The present invention is directed to an interlabial absorbentdevice. FIG. 1 shows one preferred embodiment of the interlabialabsorbent device of the present invention, interlabial device 20. Thepresent invention, however, can be in many other forms, and is notlimited to a structure having the particular configuration shown in thedrawings.

[0028] As used herein the term “interlabial absorbent device” refers toa structure which has at least some absorbent components, and isspecifically configured to reside at least partially within theinterlabial space of a female wearer during use. Preferably, at leastabout 30% of the volume of interlabial absorbent device 20 of thepresent invention resides within such interlabial space when the deviceis worn, more preferably at least about 50% of the volume resides withinsuch interlabial space, still more preferably substantially the entirevolume of interlabial absorbent device 20 resides within a wearer'sinterlabial space, and most preferably the entire interlabial absorbentdevice 20 resides within the interlabial space of a female wearer duringuse.

[0029] As used herein, the term “interlabial space” refers to that spacein the pudendal region of the female anatomy which is located betweenthe inside surfaces of the labia majora extending into the vestibule.Located within this interlabial space are the labia minor, the vestibuleand the principal urogenital members including the clitoris, the orificeof the urethra, and the orifice of the vagina. Standard medicalauthorities teach that the vestibule refers to the space boundedlaterally by the inside surfaces of the labia minora and extendinginteriorly to the floor between the clitoris and the orifice of thevagina. Therefore, it will be recognized that the interlabial space asdefined above may refer to the space between the inside surfaces of thelabia majora, including the space between the inside surfaces of thelabia minora also known as the vestibule. The interlabial space forpurposes of the present description does not extend substantially beyondthe orifice of the vagina into the vaginal interior.

[0030] The term “labia” as used herein refers generally to both thelabia majora and labia minora. The labia terminate anteriorly andposteriorly at the anterior commissure and the posterior commissure,respectively. It will be recognized by those skilled in the art thatthere is a wide range of variation among women with respect to therelative size and shape of labia majora and labial minora. For purposesof the present description, however, such differences need not bespecifically addressed. It will be recognized that the disposition ofthe interlabial absorbent device into the interlabial space of a weareras defined above will require placement between the inside surfaces ofthe labia majora without regard to the precise location of the boundarybetween the labia majora and the labia minora for a particular wearer.For a more detailed description of this portion of the female anatomy,attention is directed to Gray's Anatomy, Running Press 1901 Ed. (1974),at 1025-1027.

[0031] As used herein the term “solid component of bodily fluids” refersto particles having an effective radius of greater than about 5 microns.

[0032] The interlabial absorbent device 20 shown in FIG. 1 has alongitudinal centerline L which runs along the “x” axis shown in FIG. 1.The term “longitudinal”, as used herein, refers to a line, axis ordirection in the plane of the interlabial device 20 that is generallyaligned with (e.g., approximately parallel to) a vertical plane whichbisects a standing wearer into left and right body halves when theinterlabial device 20 is worn. The terms “transverse,” “lateral,” or “ydirection” as used herein, are interchangeable, and refer to a line axisor direction that is generally perpendicular to the longitudinaldirection. The lateral direction is shown in FIG. 1 as the “y” directionand is defined by the lateral centerline “T”. The “z” direction, shownin FIG. 1, is a direction perpendicular to the plane formed by thelongitudinal centerline L and the lateral centerline T. The term “upper”refers to an orientation in the z-direction toward the wearer's head.“Lower” or downwardly is toward the wearer's feet.

[0033] As shown in FIG. 1, the interlabial device 20 comprises a mainabsorbent portion (or “central absorbent”) 22, and a pair of flexibleextensions 24 joined to the main absorbent portion 22. The mainabsorbent portion 22 should be at least partially absorbent. The mainabsorbent portion 22 comprises an acquisition member 26 disposed alongthe longitudinal centerline of the interlabial device 20 and a storagemember 28 disposed laterally outboard of at least one of the sides ofthe acquisition member 26. Preferably, the storage member 28 comprisestwo portions with one portion being disposed laterally outboard of eachof the sides (L, z plane) of the acquisition member 26. The flexibleextensions 24 are joined to the main absorbent portion 22 adjacent theproximal end 22A thereof In use, the proximal end 22A is positionedfurthest inward into the wearer's interlabial space. In the preferredembodiment shown in FIG. 1, the interlabial device 20 also comprises aliquid impervious backsheet 38 to prevent absorbed exudates from leakingout of the main absorbent portion 22.

[0034] The interlabial device 20 should be of a suitable size and shapethat allows at least a portion thereof to fit comfortably within thewearer's interlabial space covering a wearer's vaginal orifice, andpreferably also the wearer's urethral opening. The interlabial device 20at least partially blocks, and more preferably completely blocks andintercepts the flow of menses, urine, and other bodily exudates from thewearer's vaginal orifice and urethral opening.

[0035] The size of the interlabial device 20 is also important to thecomfort associated with wearing the device. In the preferred embodimentshown in FIG. 1, the main absorbent portion 22 of the interlabial device20 has a length as measured along the longitudinal centerline, L, ofbetween about 35 mm and about 120 mm. Preferably, the length of theinterlabial device 20 is between about 40 mm and about 100 mm, and morepreferably, is between about 45 mm and about 90 mm. The dry caliper (orwidth) of the main absorbent portion 22 of the interlabial device, asmeasured in the lateral direction (or “y”-direction) under a confiningpressure of 0.25 pounds per square inch (1.7 kPa), is preferably lessthan or equal to about 15 mm, more preferably the dry caliper is lessthan about 10 mm. Still more preferably, the dry caliper is less thanabout 8 mm. A method for dry caliper measurement is provided in the TESTMETHODS section below. The depth (or “z”-direction dimension) of themain absorbent portion 22 is preferably between about 8 mm and about 35mm, and more preferably about 20 mm.

[0036] The interlabial device 20 is preferably provided with sufficientabsorbency to absorb and retain the exudates discharged from thewearer's body. The capacity of the product, however, is dependent atleast partially upon the physical volume of the interlabial absorbentdevice 20, particularly the main absorbent portion 22 thereof The mainabsorbent portion 22 preferably has a capacity of at least about 1 gramof sheep's blood as measured according to the Absorbent Capacity testdescribed in the TEST METHODS section below, and may have a capacity ofup to about 30 g by using absorbent gels or foams that expand when wet.Capacities may typically range from about 3 to about 12 grams. Thoseskilled in the art will recognize that, although they are related, thecapacity for absorption of bodily exudates such as menses will typicallydiffer somewhat from the absorbent capacity for sheep's blood. Since theinterlabial space can expand, larger volumes can be stored in theinterlabial space, if the fluid is stored as a gel, which adjusts to thebody pressures. Additionally, if the interlabial absorbent device 20does not reside completely within the wearer's interlabial space, someof the absorbed exudates may be stored externally to the wearer'sinterlabial space.

[0037] The Main Absorbent Portion

[0038] In the preferred embodiment of the interlabial absorbent device20 shown in FIGS. 1 and 2, the main absorbent portion 22 comprises anacquisition member 26 and a storage member 28. The acquisition member 26rapidly acquires bodily exudates, such as menses or urine, beforepassing them on to the storage member 28 which absorbs and retains thebodily exudates. Preferably, the acquisition member 26 has a structuretailored to rapid acquisition of such bodily fluids and the storagemember 28 has a structure tailored to “drawing” at least a portion ofthe acquired fluids from the acquisition member 26 for storage therein.While such structures will be discussed in detail below, the acquisitionmember 26 for one preferred embodiment of the present inventioncomprises a fibrous assembly having a first density and the storagemember 28 comprises a fibrous assembly having a second, higher density.The relative densities or the acquisition member 26 and the storagemember 28 are such that the acquisition member 26 can rapidly acquirebodily fluids that comprise undissolved components (e. g. cellulardebris) and high viscosity components (e. g. mucosal components), aswell as more fluid components, without substantial clogging while beingable to “give up” at least a portion of such bodily fluids to thestorage member 28. In other words, the acquisition member 26 willpreferably have a relatively low density (and a relatively large porevolume distribution) and the storage member will have a higher density(and smaller pores).

[0039] As is clearly shown in FIGS. 1 and 2, for the preferredembodiment of the present invention, the acquisition member 26 isdisposed along the longitudinal centerline L where it is in a positionto acquire such bodily exudates as they are discharged from the vaginalintroitus or the urethra. As is also shown in FIGS. 1 and 2, the storagemember 28 of this preferred embodiment comprises two portions, oneportion being disposed laterally outboard of each side of theacquisition member 26 (One of skill in the art will recognize that asingle portion lying laterally outboard of one side of the acquisitionmember 26 is also suitable). Each of the portions of the storage member28 is in effective fluid connection with, and preferably joined to, theacquisition member 26. As used herein, the term “fluid communication” isintended to mean that bodily fluids can be transferred between twoelements of the interlabial absorbent device 20 by capillary or othermeans.

[0040] The main absorbent portion 22 may be manufactured in a widevariety of shapes. Non limiting examples include ovoid, trapezoidal,rectangular, rounded rectangular, triangular, cylindrical, hemisphericalor any combination of the above. A rounded rectangular shape isparticularly preferred because such a shape eliminates sharp cornersthat may be uncomfortable. Preferably, as is shown in FIG. 1, the mainabsorbent portion 22 extends the entire longitudinal length of theinterlabial absorbent device 20. In an alternative preferred embodimentof the present invention, the main absorbent portion 22 is centeredabout the lateral centerline T and extends only a portion of thelongitudinal length of the flexible extensions 24. Such an embodiment isshown as 120 in FIG. 3 and discussed in greater detail in theAlternative Embodiments section below.

[0041] Acquisition Member

[0042] The acquisition member 26 receives bodily fluids (e. g. menses)as such fluids are released and rapidly acquires them. The acquisitionmember 26 of the present invention is particularly able to acquire suchbodily fluids over substantially the entire wear cycle of theinterlabial absorbent device 20 without surface clogging caused by solidor high viscosity components of such fluids that would interfere withsuch rapid acquisition.

[0043] In order to enable such rapid acquisition without clogging, theacquisition member 26 has larger pores relative to the pores of thestorage member 28 such that the acquisition member 26 can acquire bodilyexudates without being clogged by the suspended solid or high viscositycomponents of the exudates while “giving up” (partitioning) theremaining fluid portion of bodily exudates to the storage member 28. Forthe acquisition member 26 and the storage member 28 to function in thismanner, the acquisition member 26 should have a high percentage of poresthat are larger than the range of pores the storage member 28. Statedanother way, the mean capillary radius of the pore volume distributionof the acquisition member 26 should be larger than the mean capillaryradius of the pore volume distribution of the storage member 28. As usedherein, the term “capillary radius” is intended to mean the equivalentradius as measured during the desorption step (increasing hydrostaticpressure) according to the Pore Volume Distribution test described inthe TEST METHODS section below. To be suitable as an acquisition member26, a material should have a pore volume distribution such that at least75 percent of the pores therein have a capillary radius greater thanabout 20 microns. Preferably, at least 75% of the pores have a capillaryradius greater than about 30 microns. Still more preferably at leastabout 75% of the pores have a capillary radius greater than about 50microns. Particularly preferred materials have a pore volumedistribution such that at least 75% of the pores have a capillary radiusgreater than about 75 microns. The Applicants have found that, as longas the acquisition member 26 has such a capillary radius or larger, thesolid and viscous components of menses do not substantially interferewith the acquisition of such bodily fluids over most of the wear cycleof the interlabial absorbent device 20. As will be discussed in detailbelow, the smaller pores of the storage member 28 can then acquire thelower viscosity components from the acquisition member 26 because of thehigher capillary suction provided by the smaller pores.

[0044] The acquisition member 26 is also preferably possesses wetresiliency in order to maintain its ability to acquire solid and viscouscomponents of bodily exudates after the acquisition member has becomewet with bodily fluids. As used herein, a material having “wetresiliency” maintains at least about 60% of its initial wet caliperafter being compressed to 50% of its initial wet caliper as described inthe TEST METHODS section below. Preferably, the acquisition member 26comprises a material that has a wet resiliency of at least about 70%.

[0045] Materials that will acquire solid and viscous components of thebodily exudates without substantial clogging include both wovenmaterials, nonwoven materials, absorbent foams; absorbent sponge. Suchmaterials should be either intrinsically hydrophilic or treated tobecome hydrophilic so water-based bodily fluids can spread rapidlythereon. Suitable woven and nonwoven materials can be comprised ofnatural fibers (e.g., cellulosic fibers), hydrophilic synthetic fibers(e.g., polymeric fibers, such as polyester, rayon, polypropylene, orpolyethylene fibers, that have been treated to be hydrophilic) or from acombination of natural and synthetic fibers. Fibers usefull inmanufacturing materials suitable for use as an acquisition member 26preferably have a relatively smooth surface so as to not provide “snags”that can interfere with the rapid absorption of the solid and viscouscomponents of bodily exudates such as menses. When the acquisitionmember 26 comprises a foam material, the foam can either be a blown foam(e. g., a blown polyurethane foam), a high internal phase emulsion(HIPE) foam, or other foam as may be known to the art.

[0046] Suitable cellulosic fibers are the chemically cross-linked andstiffened, twisted (curled) fibers which are discussed more fully inU.S. Pat. No. 4,898,642 to Moore, et al., the disclosure of which ishereby incorporated herein by reference. Such fibers may be formed intoa web suitable for use as an acquisition member 26 using air laying orwet laying techniques as are familiar to the art. Preferably, the fibersare air laid as described in commonly assigned U.S. Pat. No. 5,607,414,issued to Richards, et al. on Mar. 4, 1997, the disclosure of which ishereby incorporated herein by reference. Such fibers are preferablythermally bonded by a thermoplastic material as is also described in theaforementioned U.S. Pat. No. 5,607,414.

[0047] A suitable foam material for the acquisition member 26 is theHIPE foam described in U.S. Pat. No. 5,563,179, issued to Stone, et al.,on Oct. 8, 1996. Also suitable is the polyurethane foam marketed byFoamex Corp. of Eddystone, Pa. as SIF 100. Such polyurethane foams wouldrequire treatment with a suitable surfactant so it would be sufficientlyhydrophilic for use as an acquisition member 26.

[0048] A preferred material for the acquisition member 26 comprises aneedle punched, carded rayon nonwoven material having a basis weightbetween about 65 grams per square meter and about 75 grams per squaremeter and a density of between about 0.01 grams per cubic centimeter andabout 0.05 grams per cubic centimeter, preferably between about 0.02grams per cubic centimeter and about 0.04 grams per cubic centimeter.Such a material, with a basis weight of about 69 grams per square meterand a density of about 0.03 grams per cubic centimeter, is availablefrom Stems Technical Textiles, Inc. of Lockland, Ohio as material 9290B.

[0049] A particularly preferred nonwoven material for the acquisitionmember 26 comprises a thermally bonded air laid nonwoven material. Asuitable thermoplastic staple fiber for such a nonwoven comprises apolyethylene/polypropylene bicomponent material (18 d-tex×5 millimeter)with a hydrophilic finish and is available from Chisso Corporation ofOsaka, Japan. The preferred nonwoven material comprises 100 percent ofsuch thermoplastic staple fibers. The air laying and thermal bondingmethods described in the aforementioned U.S. Pat. No. 5,607,414, can beused to form a nonwoven web having a basis weight of about 60 grams persquare meter and a dry caliper of about 2.3 millimeters from suchfibers. This nonwoven material has been found to have a pore volumedistribution such that at least 75% of the pores have a capillary radiusgreater than about 200 microns.

[0050] As can be seen in FIGS. 1 and 2, the acquisition member 26 ispreferably positioned along the longitudinal centerline L of theinterlabial absorbent device 20. As can also be seen the acquisitionmember 26 extends for substantially the entire longitudinal length ofthe main absorbent portion 22. The depth of the acquisition member 26 isalso defined by the depth of the main absorbent portion 22. As is alsoshown for the preferred embodiment shown in FIGS. 1 and 2, theacquisition member 26 is disposed between the two portions of thestorage member 28. Preferably, the acquisition member has a lateralwidth (dry caliper) of between about 1.0 millimeter and about 4millimeters. More preferably, the lateral width is between about 1.5millimeters and about 2.5 millimeters.

[0051] The structure shown in FIGS. 1 and 2 is particularly advantageousfor acquisition and storage of bodily fluids such as menses. As can beseen in FIG. 7, when the interiabial absorbent device 20 of the presentinvention is worm, the main absorbent portion 22 (and, necessarily, theacquisition member 26) has a substantially vertical orientation. Thismeans that gravity and capillary suction cooperate when the acquisitionmember 26 acquires bodily fluids as they are released. Such cooperationcan cause such bodily fluids, particularly the solid and viscouscomponents thereof to be drawn down into the acquisition member 26 andaway from the proximal surface 22A of the main absorbent portion.Because such fluids are drawn away from the proximal surface 22A, therisk of clogging any pores of the acquisition member 26 that may lienear that surface is reduced.

[0052] The Storage Member

[0053] As noted above, the storage member 28 absorbs and retains bodilyexudates such as menses or urine, and need not have an absorbentcapacity much greater than the total amount of exudate to be absorbed.In particular, the storage member 28 draws fluids from the acquisitionmember 26 because of the higher capillary suction of the materialscomprising the storage member 28. The higher capillary suction of thestorage member 28 results from the smaller pores therein. The storagemember 28 should have a pore volume distribution wherein the meancapillary radius ranges between about 5 microns and about 50 microns,preferably between about 10 microns and about 40 microns, to providesufficient capillary suction to draw fluid components of the bodilyexudates from acquisition member 26 into the storage member 28.

[0054] It is important to insure that the majority of the pores of astorage material are small enough to provide sufficient capillarysuction. Such materials preferably have pore volume distributions suchthat at least about 75% of the pores of the material have a capillaryradius of less than about 80 microns. More preferably, such materialshave a pore volume distribution such that at least about 75% of thepores of the material have a capillary radius less than about 60microns. Particularly preferred materials have a pore volumedistribution such that at least about 75% of the pores of the materialhave a capillary radius of less than about 45 microns.

[0055] It is also important that the pore volume distribution of amaterial suitable for use as a storage member 28 be sufficiently largethat the pores thereof are not readily clogged by undissolved componentsof bodily fluids (e. g. cellular debris). Such clogging can block flowthrough the storage member 28 so that a portion of the storage member 28may not be available for storage of bodily fluids. Preferably materialsused as a storage member 28 have a pore volume distribution such thatless than about 10% of the pores have a capillary radius of less than 5microns. More preferably, the pore volume distribution is such that lessthan about 15% of the pores have a capillary radius of less than about 5microns.

[0056] The storage member 28 of the preferred embodiment shown in FIGS.1 and 2 may comprise any suitable type of absorbent structure that iscapable of absorbing and/or retaining bodily exudates (e.g. mensesand/or urine) and of drawing such exudates from the acquisition member.The storage member 28 may be manufactured and from a wide variety ofliquid-absorbent materials commonly used in absorbent articles such ascomminuted wood pulp which is generally referred to as airfelt. Examplesof other suitable absorbent materials include creped cellulose wadding;meltblown polymers including coform; chemically stiffened, modified orcross-linked cellulosic fibers; synthetic fibers such as crimpedpolyester fibers; peat moss; tissue including tissue wraps and tissuelaminates; absorbent foams; absorbent sponges; superabsorbent materials,such as superabsorbent polymers and absorbent gelling materials; or anyequivalent material or combinations of materials, or mixtures of these.The storage member 28 may comprise a single material or a combination ofmaterials, such as a wrapping layer surrounding a central waddingcomprised of a different absorbent material.

[0057] A suitable combination of materials for the storage member 28comprises a laminate of a fibrous absorbent gelling material disposedbetween two plies of air laid tissue. In this embodiment, the absorbentgelling material is provided at a level of between about 0.005 gram persquare centimeter and about 0.15 grams per square centimeter, preferablybetween about 0.007 grams per square centimeter and 0.07 grams persquare centimeter. A suitable absorbent gelling material is availablefrom Courtaulds Fibers/Allied Colloids, a joint venture company, WestMidlands, England as OASIS and a suitable tissue is an airlaid tissueavailable from Fort Howard Tissue Company of Green Bay, Wis., and havinga basis weight of 35 lbs. per 3000 sq. ft (57 grams per square meter).

[0058] Alternatively, an air laid combination of cellulosic fibers asare commonly known to the art and an absorbent gelling material is alsosuitable for use as a storage member 28. For example, the Applicantshave found that such an air laid combination having a basis weight of0.025 grams per square centimeter and comprising about 17% Fiberdri 1160available from Camelot Superabsorbents, Ltd. of Calgary, Alberta, Canadais particularly suitable.

[0059] For designs where use of absorbent gelling materials isundesirable, cotton wadding having a basis weight between about 75 gramsper square meter and about 250 grams per square meter and a dry caliperof between about 0.5 millimeters and about 3.0 millimeters is preferred.A particularly preferred cotton wadding, having a basis weight of about190 grams per square meter and a dry caliper of about 1.3 millimeters,is available from REVCO DS, Inc. of Twinsburg, Ohio as Cotton CosmeticSquares (Item 2736).

[0060] As is shown in FIGS. 1 and 2, the storage member 28 for thispreferred embodiment of the present invention comprises two portionswith one portion lying on either side of the acquisition member 26 andlaterally outboard thereof. As can also be seen each portion extendssubstantially the entire longitudinal length of the main absorbentportion 22 and the full depth thereof. The thickness (dry caliper) ofeach portion of the storage member 28 is preferably between about 4percent and about 40 percent of the dry caliper of the main absorbentportion 22. More preferably, the thickness is between about 10 percentand about 30 percent of the dry caliper of the main absorbent portion22.

[0061] Such a structure maximizes the contact area between theacquisition member 26 and the storage member 28. As a result, theinterlabial absorbent device 20 of the present invention makes full useof available storage capacity. As was discussed with respect to theacquisition member 26, gravity and capillary suction can cooperate todraw bodily fluids down into the acquisition member 26. Since thepreferred structure shown in FIGS. 1 and 2 provides for verticallyoriented contact between the acquisition member 26 and the storagemember 28 throughout one major face of the acquisition member 26, fluidsthat have been drawn deep into the acquisition member 26 can be drawninto the storage member 28 at the same depth. This means that fullutilization of the available storage capacity of the storage member 28does not only depend on lateral flow through the storage member 28 aswould be necessary if there were no acquisition member 26. As a result,localized portions of the storage member 28 are less likely to becomesaturated before the full absorbent capacity of the storage member 28 isutilized.

[0062] Flexible Extensions

[0063] As shown in FIGS. 1 and 2, the interlabial absorbent device 20also comprises a pair of flexible extensions 24 which are joined to mainabsorbent portion 22 adjacent the proximal surface 22A thereof In thepreferred embodiment shown in FIGS. 1 and 2, the flexible extensions 24are generally rectangular in shape. Other shapes are also possible forthe flexible extensions 24 such as semi-circular, trapezoidal, ortriangular. The flexible extensions 24 preferably are from about 40 mmto about 160 mm in length, more preferably from about 45 mm to about 130mm in length, and most preferably from about 50 mm to about 115 mm inlength. While the flexible extensions 24 can have a longitudinal lengthwhich is shorter than the main absorbent portion 22, preferably theyhave a length which is the same as or longer than the main absorbentportion 22. The width of a flexible extension refers to the distancefrom the attachment of flexible extension 24 to the main absorbentportion 22 (or the proximal end 24A of the flexible extension 24) to thedistal end (or free end) 24B of the flexible extension 24. The width ofa flexible extension 24 is preferably about equal to or greater than thedepth of the main absorbent portion 22 as described above. The drycaliper of the flexible extensions is preferably less than or equal toabout 3 mm, more preferably less than or equal to about 2 mm, and mostpreferably less than or equal to about 1 mm. Ideally the dry caliper ofthe flexible extensions 24 and the main absorbent portion 22 areselected such that the dry caliper of the overall absorbent interlabialstructure 20 is less than or equal to about 8 mm.

[0064] The flexible extensions 24 may be constructed from any materialhaving the requisite flexibility and dry caliper. Suitable materialsinclude: woven and nonwoven materials; polymeric materials such asapertured formed thermoplastic films, apertured plastic films, andhydroformed thermoplastic films; porous foams; reticulated foams;reticulated thermoplastic films; and thermoplastic scrims. Suitablewoven and nonwoven materials can be comprised of natural fibers (e.g.,wood or cotton fibers), synthetic fibers (e.g., polymeric fibers such aspolyester, rayon, polypropylene, or polyethylene fibers) or from acombination of natural and synthetic fibers.

[0065] A preferred material for constructing the flexible extensions 24is a tissue layer. A suitable tissue is an airlaid tissue available fromFort Howard Tissue Company of Green Bay, Wis., and having a basis weightof 35 lbs. per 3000 sq. ft (57 grams per square meter). Another suitableairlaid tissue is available from Merfin Hygienic Products, Ltd., ofDelta, British Columbia, Canada, having a basis weight of 61 grams persquare meter and having the designation grade number 176. Although notnecessary for the operation of the present invention, the flexibleextensions 24 are preferably backed by the backsheet 38 as is describedbelow.

[0066] In the preferred embodiments shown in FIGS. 1 and 2 the pair offlexible extensions 24 may comprise separate sheets of materialindependently joined to the main absorbent portion 22 adjacent theproximal surface 22A thereof. Preferably, the flexible extensions 24 arearranged symmetrically about the longitudinal centerline L of the mainabsorbent portion 22. More preferably, the flexible extensions 24 arejoined to the proximal surface 22A of the main absorbent portion 22within about 3 mm of that surface.

[0067] The term “joined”, as used herein, encompasses configurations inwhich an element is directly secured to another element by affixing theelement directly to the other element; configurations in which theelement is indirectly secured to the other element by affixing theelement to intermediate member(s) which in turn are affixed to the otherelement; and configurations in which one element is integral withanother element; i.e., one element is essentially part of the otherelement.

[0068] Backsheet

[0069] The preferred embodiment of the interlabial absorbent device 20shown in FIGS. 1 and 2 further comprises a backsheet 38 positioned overand joined to all or a portion of its back surface, including theflexible extensions 24.

[0070] The backsheet 38 is preferably impervious or semi-pervious toliquids (e.g., menses and/or urine) and flexible. As used herein, theterm “flexible” refers to materials which are compliant and will readilyconform to the general shape and contours of the human body. Thebacksheet 38 prevents the exudates absorbed and contained in the mainabsorbent portion 22 from wetting articles which contact the interlabialabsorbent device 20 such as the wearer's undergarments. The backsheet 38also assists the main absorbent portion 22 in preventing the wearer'sbody from being soiled by exudates. Additionally, use of a backsheet mayprovide an improved (e.g. more sanitary) surface for the wearer to graspbetween her fingers as the interlabial absorbent device 20 is inserted,or as the soiled device is optionally removed with the fingers.

[0071] The backsheet 38 may comprise a woven or nonwoven material,polymeric films such as thermoplastic films of polyethylene orpolypropylene, or composite materials such as a film-coated nonwovenmaterial. Preferably, the backsheet is a polyethylene film having athickness of from about 0.012 mm (0.5 mil) to about 0.051 mm (2.0 mils).An exemplary polyethylene film is manufactured by Clopay Corporation ofCincinnati, Ohio, under the designation P18-0401. The backsheet 38 maypermit vapors to escape from the main absorbent portion 22 (i.e.,breathable) while still preventing exudates from passing through thebacksheet.

[0072] Optional Components

[0073] The interlabial device 20 in any of the embodiments shown in thedrawings may comprise other optional components.

[0074] Topsheet

[0075] For example, the interlabial device 20 may comprise a topsheetpositioned over and joined to all or a portion of the body facingsurface of the device 20. Preferably, if a topsheet is used, it isjoined to at least a portion of the main absorbent portion 22.Preferably, a topsheet, when used, is disposed on and joined to both theproximal surface 22A of the main absorbent portion 22 and the bodyfacing surface of the flexible extensions 24.

[0076] If a topsheet is used, the topsheet should be compliant, softfeeling, and non-irritating to the wearer's skin. Further, the topsheetshould be liquid pervious permitting liquids (e.g., menses and/or urine)to readily penetrate through its thickness. A suitable topsheet may bemanufactured from a wide range of materials such as woven and nonwovenmaterials; polymeric materials such as apertured formed thermoplasticfilms, apertured plastic films, and hydroformed thermoplastic films;porous foams; reticulated foams; reticulated thermoplastic films; andthermoplastic scrims. Suitable woven and nonwoven materials can becomprised of natural fibers (e.g., wood or cotton fibers), syntheticfibers (e.g., polymeric fibers such as polyester, rayon, polypropylene,or polyethylene fibers) or from a combination of natural and syntheticfibers.

[0077] In particular, the topsheet may comprise an apertured formedfilm. Apertured formed films are pervious to bodily exudates and, ifproperly apertured, have a reduced tendency to allow liquids to passback through and rewet the wearer's skin. Thus, the surface of theformed film which is in contact with the body remains dry, therebyreducing body soiling and creating a more comfortable feel for thewearer. Suitable formed films are described in U.S. Pat. No. 3,929,135,which issued to Thompson on Dec. 30, 1975; U.S. Pat. No. 4,324,246,which issued to Mullane, et al. on Apr. 13, 1982; U.S. Pat. No.4,342,314, which issued to Radel, et al. on Aug. 3, 1982; U.S. Pat. No.4,463,045, which issued to Ahr, et al. on Jul. 31, 1984; and U.S. Pat.No. 5,006,394, which issued to Baird on Apr. 9, 1991. The preferredtopsheet for the present invention is the formed film described in oneor more of the above patents and marketed on sanitary napkins by TheProcter & Gamble Company of Cincinnati, Ohio as the “DRI-WEAVE”topsheet.

[0078] The body contacting surface of a preferred formed film topsheetis also hydrophilic so as to help liquid to transfer through thetopsheet faster than if the body contacting surface was not hydrophilicso as to diminish the likelihood that menstrual fluid will flow off thetopsheet rather than flowing into and being absorbed by the mainabsorbent portion 22. In a preferred embodiment of such a topsheet,surfactant is incorporated into the polymeric materials of the formedfilm topsheet. Alternatively, the body contacting surface of thetopsheet can be made hydrophilic by treating it with a surfactant suchas is described in U.S. Pat. No. 4,950,254 issued to Osborn.

[0079] Body Adhesive

[0080] Optionally, the flexible extensions 24 may also be provided witha biocompatible adhesive to assist the adhesion of the flexibleextensions 24 to the inside surfaces of the wearer's labia. The strengthof such an adhesive should be selected to assist the interlabialabsorbent device 20 in staying in place, while still allowing forreliable, and comfortable removal of the device from the wearer'sinterlabial space. Suitable adhesives are discussed in U.S. Pat. No.5,336,208, issued to Rosenbluth, et al. on Aug. 9, 1994, the disclosureof which is incorporated herein by reference.

[0081] Alternative Embodiments

[0082] Several alternative preferred embodiments of the presentinvention are also contemplated. Examples of such embodiments arediscussed below.

[0083] Extended Flexible Extensions

[0084] In the alternative embodiment, interlabial device 120, which isshown in FIG. 3, the longitudinal length of the main absorbent portion122 is only a fraction of the longitudinal length of the flexibleextensions 124. Such a structure has the advantage having a smallervolume and, as a result, taking up a smaller portion of the volume of awearer's interlabial space than embodiment shown in FIGS. 1 and 2,interlabial device 20. Conversely, the main absorbent portion 122 ofalternative interlabial device 120 will have a lower overall capacitythan the main absorbent portion 22 of interlabial device 20.

[0085] Overall, each of the components of alternative interlabial device120 comprise the same elements as interlabial device 20. However, asnoted above the size relationships between the components differ. Inparticular, the main absorbent portion 122 alternative interlabialdevice 120 has a smaller longitudinal length than the main absorbentportion 22 of interlabial device 20. Depending on the desiredrelationship between device volume and absorbent capacity, the mainabsorbent portion 122 may have a longitudinal length of between about30% and about 90% of the longitudinal length of the flexible extensions124. Preferably, the longitudinal length of the main absorbent portion122 is between about 30% and about 60% of the longitudinal length of theflexible extensions 124.

[0086] Alternative embodiments (not shown) wherein the longitudinallength of the flexible extensions is less than the longitudinal lengthof the main absorbent portion are also contemplated with respect to thepresent invention. Preferably, such flexible extensions are centeredabout the transverse centerline of such embodiments and extend in thelongitudinal direction for at least about one third of the longitudinallength of the main absorbent portion.

[0087] In a variation of this alternative embodiment (not shown), thedepth of the main absorbent portion 122 can be greater than the lateralwidth of one of the flexible extensions 124. Such a structure canprovide additional absorbent capacity while compensating for some of thevolume loss to the main absorbent portion 122 caused by decreasing thelongitudinal length thereof

[0088] Pleated Main Absorbent Portion

[0089] In an alternative preferred embodiment, interlabial device 220,shown in FIG. 4, the storage member 228 comprises a pleated structure.As shown in FIG. 4, the storage member 228 comprises a folded tissueweb. The folded tissue web preferably has a strength greater than thatof standard non-wet strength toilet tissue. Preferably, the storagemember 228 comprises a tissue having a temporary wet strength of greaterthan or equal to about 50 grams as measured according to the wet burststrength method described in the TEST METHODS section below. Preferablythe temporary wet strength is greater than or equal to about 100 g. In apreferred design this wet strength will decay to about 50% or less ofthe original strength over about 30 minutes.

[0090] As shown in FIG. 4, the tissue web comprising the storage member228 is folded into a pleated structure comprising a plurality of pleats230 that are arranged in a laterally side-by-side relationship. Thetissue web can be folded so that it has any suitable number of pleats.Preferably, the tissue web is folded so that the overall dry caliper(i.e., the width) of the storage member 228 of this embodiment isbetween about 2 mm and less than or equal to about 7 mm.

[0091] The pleats 230 in the folded tissue web are preferably connectedor joined (or retained) in some suitable manner so that the pleatedsections maintain their pleated configuration, and are not able to fullyopen. The pleats can be connected by a variety of means including theuse of thread, adhesives, or heat sealing tissues which contain athermoplastic material, such as, polyethylene. A preferred design usesstitching which joins all of the pleats 230 in the storage member 228together. Preferably, the main absorbent structure 222 is provided withfive stitch locations (four at the corners and one additional locationapproximately midway between the two lower corners).

[0092] The alternative preferred embodiment shown in FIG. 4, preferablyhas a storage member 228 and flexible extension 224 dimensions similarto those described above for the embodiment shown in FIGS. 1 and 2. Thewidth of the storage member 228 of the interlabial device 220 asmeasured in the lateral direction (y-direction) is preferably betweenabout 1 mm and about 2 mm. Preferably, in a preferred embodiment, thewidth of the main absorbent portion of the interlabial device 20 isabout 4.5 mm.

[0093] The pleated design shown in FIG. 4 has the additional benefit ofeasily providing the flexible extensions 224. The extensions 224 cancomprise the same material as the storage member 228, or they cancomprise a different material. The extensions 224 are disposed withinabout 1 millimeter of or, preferably, adjacent to the proximal surface222A of the main absorbent portion 222 and joined thereto. Morepreferably, as is shown in the embodiment of FIG. 4, the extensions 224are integral portions of the storage member 228 (that is, the extensions224 comprise integral extensions of the absorbent tissue material thatis folded to form the storage member 228).

[0094] The acquisition member 226 and the flexible extensions 224 of theinterlabial absorbent device 20 shown in FIG. 4 may be constructed fromany of the materials discussed with respect to the equivalent members inthe embodiment shown in FIGS. 1 and 2. Similarly, this alternativepreferred embodiment also comprises a backsheet 238 disposed on thelower surface thereof.

[0095] In a variation of the structure of FIG. 4, which is shown in FIG.5 as interlabial device 250, both the acquisition member 226 and thestorage member 228 are pleated. Such a structure has the additionalbenefit of increased surface contact between the acquisition member 226and the storage member 228 because the storage pleats 203 and theacquisition pleats 232 are inter meshed. One skilled in the art willrecognize that the dry caliper of the main absorbent portion 222 of thisalternative embodiment is determined by wearer comfort. As a result, thematerial comprising the acquisition member 226 of this embodiment isthinner (has a lower dry caliper) than the material comprising theembodiment shown in FIG. 4. However, because of the folded nature of theacquisition pleats 232, the proximal surface 222A of interlabial device250 has a body contact area similar to the body contact area of theproximal surface 222A of interlabial device 220 of FIG. 4.

[0096] In another variation of the pleated structure shown in FIG. 4,the storage member 328 may comprise a plurality of individual layers 332joined in a face-to-face relationship. Such a device is shown in FIG. 6as interlabial device 320. Interlabial device 320 may have all of thesame characteristics described above for the pleated structure 220. Onebenefit of the use of a plurality of individual layers 332 is that thevarious layers may comprise different materials with differentproperties or characteristics. Each of the flexible extensions 324 maybe integral with one of the individual layers 332 or may be joinedseparately to the upper portion 326 of the storage member 328.Preferably, the individual layers 332 are arranged in a side-by-siderelationship so that the spaces between the layers are oriented in thez-direction (as shown in FIG. 6).

[0097] As previously discussed, the interlabial absorbent device 20 ofthe present invention is preferably designed to be placed entirelywithin the interlabial space of a wearer. To use the interlabialabsorbent device 20 of the present invention, the wearer holds the mainabsorbent portion 22 between her fingers. As shown in FIG. 7, theflexible extensions 24 are spread apart so as to cover the tips of thewearer's fingers during insertion. This feature provides for a hygienicinsertion of the interlabial absorbent device 20 of the presentinvention. The proximal surface 22A is inserted first and furthest intothe interlabial space. The wearer may assume a squatting position duringinsertion to assist in spreading the labial surfaces. Once theinterlabial absorbent device 20 is inserted, the flexible extensions 24tend to adhere to the inside surfaces of the labia. When the wearer isstanding, the labial walls close more tightly around the interlabialabsorbent device 20 as shown in FIG. 8.

[0098] The interlabial device 20 is preferably at least partiallyretained in place by exerting a slight laterally outwardly-orientedpressure on the inner surfaces of the wearer's labia minora, labiamajora, or both. Additionally, the product is also held by attraction ofnaturally moist labial surfaces to the tissue comprising the flexibleextensions 24.

[0099] The interlabial absorbent device 20 can be worn as a “standalone” product. Alternatively, it can be worn as a back up to a tampon,or in combination with a sanitary napkin, pantiliner, or incontinencepad for menstrual or incontinence use. If the interlabial absorbentdevice 20 is used with a sanitary napkin, the sanitary napkin can be ofany thickness. Use with a sanitary napkin may be preferred at night toreduce rear soiling. The interlabial device 20 can be worn inconventional panties, or it can be used with menstrual shorts.

[0100] Numerous alternative embodiments of the interlabial absorbentdevice of the present invention are possible. For example, theseproducts are designed to be removed by urination, although analternative extraction string or loop may be used. These products mayalso be used with medicinal treatments. These products may beconstructed of materials which are biodegradable and/or which willfragment in water with agitation (as in a toilet). The interlabialabsorbent device 20 may also be constructed with a plurality of slits inthe main absorbent portion 22 so as to permit bending of the product inmultiple independent directions. Such a structure allows the product tomore easily respond to the stresses associated with body movements. In apreferred version of the embodiment shown in FIG. 4, the ends of thesurface of the central absorbent facing away from the body may berounded to reduce the force on the product during sitting. The topsurface of the structure may have one or more slits or have otherregions of preferred bending so that product may easily adjust to thevertical pressure against the pelvic floor, to help accommodate thenon-linear surface of the pelvic floor between the clitoris and theperineum. The flexible extensions 24 of the absorbent devices describedabove may also act as a spring in both wet and dry conditions such thatthe sides of the product tend to expand outward pressing against thelateral walls of the labial vestibule, thereby, holding the product inplace. In addition, it is preferred that the flexible extensions 24maintain the ability to act as a “spring” when wet, such as when theproduct is saturated with liquid. Structures, such as polyurethane foamscan provide these properties.

TEST METHODS

[0101] Dry Caliper

[0102] Principle

[0103] Dry caliper of a sample can be determined using a comparatorgauge that is weighted to provide a predetermined confining pressure.

[0104] Apparatus

[0105] A suitable comparator gauge gage is the Ames, Model 130 with dialindicator Model 482, available from the B. C. Ames, Company of Waltham,Mass. The comparator gauge should have a circular comparator foot madeof aluminum capable of exerting a loading pressure of 0.25 pounds persquare inch (1.7 kPa). It will be recognized that the diameter of thecomparator foot can be varied to accommodate different sample sizes aslong as the loading pressure remains constant.

[0106] Operation

[0107] 1. The comparator gauge is zeroed according to the manufacturer'sinstructions.

[0108] 2. The comparator foot is raised and the sample is placed on thebase plate. The sample is positioned on the base plate so that when thefoot is lowered it is in the center of the sample. The comparator footshould be at least 5 millimeters from all sample edges. Try to smoothout or avoid any wrinkles in the sample.

[0109] 3. Gently lower the foot onto the sample.

[0110] 4. Determine caliper by reading the comparator dial 30 secondsafter the foot comes in contact with the sample.

[0111] 5. Repeat steps 2 through 4 for an additional 2 samples.

[0112] Calculations

[0113] The average of the three readings is the dry caliper of thematerial.

[0114] Absorbent Capacity

[0115] Principle

[0116] The total absorbent capacity of the interlabial absorbent deviceis measured as the difference between the dry and loaded weights of thedevice where the loading fluid is analogous to menses.

[0117] Apparatus

[0118] Analytical Balance

[0119]  Accurate to 0.1 gram

[0120] Fluid Container

[0121]  Glass, able to hold 1 liter with sufficient wall depth to insureno spillage when samples are inserted or removed. The container mustalso have dimensions greater than 150% of the dimensions of theinterlabial absorbent device in the x and y directions.

[0122] Filter Paper

[0123]  Available from Filtration Science Corp., Eaton-Dikeman Divisionof Mount Holly Springs, Pa. as paper #631

[0124] Test Fluid

[0125]  Sterile defibrinated sheep blood which is available fromCleveland Scientific, Inc. of Bath, Ohio. Sheep's blood is a labilematerial having a limited shelf life even when stored under appropriateconditions. It comprises a heterogeneous mixture having approximately15% by weight hemoglobin and 75-80% by weight water with low levels ofionic salts, lactic acid, and urea. The blood should be stored in asealed container at 4° C.±1° C. prior to use. It should be discardedafter two weeks if it is not used. Testing is carried out at atemperature of 23° C.±1° C. The sheep's blood should be warmed in awater bath to that temperature and agitated to insure even distributionof components before being transferred into the fluid container.

[0126] Procedure

[0127] 1) Condition the test samples by leaving them in a room at 50%relative humidity and at 73° F. (23° C.) for a period of two hours priorto the test. The test should be performed under similar conditions.

[0128] 2) Pour about 1 liter of sheep's blood into the fluid container.

[0129] 3) Weigh the test sample to the nearest 0.1 gram to determine thedry weight.

[0130] 4) Submerge the sample in the sheep's blood.

[0131] 5) Remove the article from the sheep's blood after 15 minutes.

[0132] 6) Place the article on a horizontal wire mesh screen havingsquare openings 0.25 inches×0.25 inches (64 millimeters×64 millimeters)and allow to drain for 5 minutes.

[0133] 7) Weigh the sample to the nearest 0.1 gram and record the weight

[0134] 8) Place the sample between two pieces of the filter paper andapply a uniform load of 0.25 pounds per square inch (1.7 kPa) to thesample for 35 seconds.

[0135] 9) Weigh the sample to the nearest 0.1 gram and record theweight.

[0136] 10. Increase the loading to 1 pound per square inch (6.8 kPa) andmaintain the pressure for 19 seconds.

[0137] 11. Remove the sample from between the filter paper and reweighthe sample to the nearest 0.1 gram to determine the loaded weight.

[0138] Calculation and Reporting

[0139] Absorbent capacity is defined as the difference between theloaded and the dry weights.

[0140] Pore Volume Distribution

[0141] Principle

[0142] Pore volume distribution for a sample is measured down to a poresize of about five microns using the Textile Research Institute(Princeton, N.J.) Liquid Porosimeter. This instrument (i) appliespre-selected, generally incremental, hydrostatic air pressures to asample pad that can absorb/desorb fluid through a fluid-saturatedmembrane and (ii) determines the incremental and cumulative quantity offluid that is absorbed/desorbed by the pad at each pressure. A weight ispositioned on the sample to ensure good contact between sample andmembrane and to apply an appropriate mechanical confining pressure. Afluid having a low surface tension (γ) is typically used to ensurewettability (cos(θ)=1) of fiber surfaces.

[0143] Each sample evaluation comprises an absorption/desorption cycle.In the absorption sequence cumulative volume absorbed versusincrementally decreasing hydrostatic pressure is measured. This isfollowed by a single desorption sequence where cumulative volumedesorbed versus incrementally increasing hydrostatic pressure ismeasured. Hydrostatic pressures range from a high pressure correspondingto an equivalent radius:

r=2 γcos(θ)/P

[0144] of approximately five microns to a zero or near-zero pressurecorresponding to an equivalent radius at least about 1000 microns orgreater.

[0145] Additional detail is provided by the following references:

[0146] 1. A. Burgeni and C. Kapur, Capillary Sorption Equilibria inFibrous Masses, Textile Research Journal 37, 356 (1967).

[0147] 2. H. G. Heilweil, ed., Determining Pore Size Distributions inFibrous Materials, Notes on Research, Textile Research Institute, Number363 (April 1984).

[0148] 3. B. Miller and I. Tyomkin, An Extended Range Liquid ExtrusionMethod for Determining Pore Size Distribution, Textile Res. J. 56, 35(1986).

[0149] Apparatus

[0150] Porosimeter (Available from Textile Research Institute ofPrinceton, N.J. as Model LP-5)

[0151] Membrane: MILLIPORE 0.22 μM pore size GS Filter 90 mm (Availablefrom Millipore Corp. of Bedford, Mass. as Catalog Number GSWP 090-25)

[0152] Porous Plate (Available from Fisher Scientific of Pittsburgh,Pa.)

[0153] Petree Dish Lid - 90 cm diameter

[0154] Small soft bristles brush (˜0.5″ wide)

[0155] Test Fluid

[0156] Surfactant Solution: 0.2% by weight solution of TRITON X-100(available from Rohm and Haas, Philadelphia, Pa.) in deionized waterProcedure

[0157] Sample Preparation

[0158] Shortly before measuring pore volume distribution, the caliper ofthe sample is measured (as described herein) under a confining pressureof 0.2 psi (1.4 kPa). Sample density is calculated from the weight,caliper, and area of the sample.

[0159] Confining Pressure

[0160] A confining pressure of 0.2 psi (1.4 kPa) is used for thepore-volume distribution measurement. The same or equivalent weight thatis used for determining sample density is also used for applying theconfining pressure during the pore volume measurement.

[0161] Instrumentation Configuration

[0162] Set up the porosimeter according to the instruction manual.

[0163] Absorption/Desorption Cycle Characteristics

[0164] An absorption/desorption cycle comprises two steps. First, asingle absorption sequence where cumulative volume absorbed versusincrementally decreasing hydrostatic pressure is measured. This isfollowed by a single desorption sequence where cumulative volumedesorbed versus incrementally increasing hydrostatic pressure ismeasured. Hydrostatic pressures range from a high pressure correspondingto an equivalent radius of approximately five microns to a zero ornear-zero pressure corresponding to an equivalent radius at least about1000 microns or greater.

[0165] Absorption/Desorption Procedure for an Initially Dry Sample

[0166] 1. Input parameters are entered as described in the equipmentinstructions and the controlling computer program is started.

[0167] 2. The top of the instrument test cell is secured and the ventvalve is shut. The liquid flow valve to the balance is opened. At thisstep the sample is not yet in the test cell.

[0168] 3. The controlling computer program is continued. The hydrostaticpressure adjusts to a pre-set value (i.e., STOP RADIUS) that is slightlyhigher than the first inputted pressure used in the experiment.

[0169] 4. After equilibration is signaled, the liquid valve to thebalance is shut, the test cell is opened, the sample is positioned onthe membrane, the confining weight is positioned on the sample, and thetop of the instrument test cell is secured.

[0170] 5. The program is continued and hydrostatic pressure adjusts tofirst inputted pressure.

[0171] 6. After equilibration is signaled, the fluid valve to balance isopened.

[0172] 7. The sample is cycled through a predetermined series ofpressures which correspond to specific equivalent pore radii.

[0173] Blank Subtraction

[0174] A blank run is recorded, as above, but with the test cell empty.This determines the background absorption/desorption response of thesystem and membrane. Values for cumulative absorption and desorptionvolumes versus hydrostatic pressure are obtained. These values are usedto correct the corresponding values measured for the sample.

[0175] Calculation of Normalized Cumulative Volumes

[0176] Based on the incremental volume values, the controlling computerprogram calculates blank-corrected values for cumulative volume versusequivalent pore radius. Cumulative volumes are divided by the dry weightof the pad and reported in units of mm³/mg. Cumulative volumes aredivided by the volume at saturation (i.e., the cumulative volumemeasured for the largest equivalent radius at zero or near-zeropressure) to obtain the normalized cumulative volume (expressed as %)versus equivalent pore radius.

[0177] Burst Strength

[0178] Overview

[0179] The test specimen, held between annular clamps, is subjected toincreasing force that is applied by a 0.625 inch diameter, polishedstainless steel ball. The burst strength is that force that causes thesample to fail. Burst strength may be measured on wet or dry samples.

[0180] Apparatus

[0181] Burst Tester

[0182]  Intelect-II-STD Tensile Test Instrument, Cat. No. 1451-24PGB orthe Thwing-Albert Burst Tester are both suitable. Both instruments areavailable from Thwing-Albert Instrument Co., Philadelphia, Pa. Theinstruments must be equipped with a 2000 g load cell and, if wet burstmeasurements are to be made, the instruments must be equipped with aload cell shield and a front panel water shield.

[0183] Conditioned Room

[0184]  Temperature and humidity should be controlled to remain withinthe following limits:

[0185]  Temperature: 73±3° F. (23° C.±2° C.)

[0186]  Humidity: 50±2% Relative Humidity

[0187] Paper Cutter

[0188]  Scissors or other equivalent may be used

[0189] Pan

[0190]  For soaking wet burst samples, suitable to sample size

[0191] Solution

[0192]  Water for soaking wet burst samples should be equilibrated tothe temperature of the conditioned room.

[0193] Timer

[0194]  Appropriate for measuring soak time

[0195] Sample preparation

[0196] 1) Cut the sample to a size appropriate for testing (minimumsample size 4.5 in×4.5 in). Prepare a minimum of five samples for eachcondition to be tested.

[0197] 2) If wet burst measurements are to be made, place an appropriatenumber of cut samples into a pan filled with temperature-equilibratedwater.

[0198] Equipment Setup

[0199] 1) Set the burst tester up according to the manufacturer'sinstructions. If an IntelectII-STD Tensile Test Instrument is to be usedthe following are appropriate:

[0200] Speed: 12.7 centimeters per minute

[0201] Break Sensitivity: 20 grams

[0202] Peak Load: 2000 grams

[0203] 2) Calibrate the load cell according to the expected burststrength.

[0204] Measurement and Reporting

[0205] 1) Operate the burst tester according to the manufacturer'sinstructions to obtain a burst strength measurement for each sample.

[0206] 2) Record the burst strength for each sample and calculate anmean and a standard deviation for the burst strength for each condition.

[0207] 3) Report the mean and standard deviation for each condition tothe nearest gram.

[0208] Wet Resiliency

[0209] Principle

[0210] A test sample, saturated to its free absorbent capacity with 0.9%saline solution, is compressed to one half its precompression caliper.The pressure is then released, and the sample is allowed to recoverthickness in the presence of the expelled fluid. The percent recovery isbased on the original wet caliper of the uncompressed sample.

[0211] Test Fluid

[0212] An aqueous solution of sodium chloride (0.9% saline by weight),obtainable from Baxter Travenol company of Deerfield, Ill., is used tosaturate the samples.

[0213] Equipment

[0214] Caliper Gauge

[0215]  Digital gauge with 1 inch (2.54 centimeter) diameter circularfoot, such as the Ono Sokki Model GS 503, available from Measure-All,Inc., Fairfield, Ohio

[0216] Tensile/compression Tester

[0217]  Sintech Renew Tensile/Compression running MTS Sintech 3.04software, available from MTS Systems Corporation of Eden Prairie, Minn.

[0218] Load Cell

[0219]  Suitable for tensile/compression tester, 100N

[0220] Compression Plate

[0221]  1 inch (2.54 centimeter) diameter, flat circular plate attachedto crosshead

[0222] Equipment Setup

[0223] Gauge Length

[0224]  4.00 millimeters

[0225] Crosshead Speed

[0226]  5.0 millimeters per minute

[0227] Turnaround Distance

[0228]  One half initial sample caliper

[0229] Method

[0230] 1) Cut a 10 centimeter×10 centimeter square sample from thematerial to be tested.

[0231] 2) Immerse the sample in 0.9% saline solution for 8 minutes.

[0232] 3) Measure the wet caliper using the caliper gauge under aconfining pressure of 0.1 psi (0.7 kPa).

[0233] 4) Set the turnaround distance (Gauge Length - 1.5×wet caliper)on the tensile/compression tester.

[0234] 5) Place the sample on a 140 millimeter diameter flat, circularplate on the tensile/compression tester and start the crosshead.

[0235] 6) Record the distance at a force of 32 grams (i.e., a pressureof 0.1 psi (0.7 kPa)) on the downward (Downward Distance) and return(Return Distance) cycles of the crosshead.

[0236] Calculation

Wet Resiliency=100*((Gauge Length)-(Return Distance))/((GaugeLength)-(Downward Distance))

[0237] The disclosure of all patents, patent applications (and anypatents which issue thereon, as well as any corresponding publishedforeign patent applications), and publications mentioned throughout thisdescription are hereby incorporated by reference herein. It is expresslynot admitted, however, that any of the documents incorporated byreference herein teach or disclose the present invention.

[0238] While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention.

What is claimed is:
 1. An absorbent device insertable into theinterlabial space of a female wearer, said absorbent device comprising:a body contacting surface said body contacting surface having alongitudinal centerline and defining a pair of flexible extensionswherein each of said flexible extensions is located on either side ofsaid longitudinal centerline, a liquid impervious backsheet joined tosaid absorbent device opposite said body contacting surface, and a tabportion depending from said absorbent device and joined to saidbacksheet.
 2. The absorbent device of claim 1 wherein said bodycontacting surface has a first length and said tab portion has a secondlength, wherein said first length exceeds said second length.
 3. Theabsorbent device of claim 1 wherein said body contacting surfacecomprises a liquid pervious topsheet.